Graft for treating the distal aortic arch and descending aorta in type a patients

ABSTRACT

A prosthetic graft assembly (40, 120) is disclosed for placement of a patient&#39;s aortic arch and repair of the descending aorta in a procedure which requires only a sternotomy. The assembly includes a descending graft element (40) which includes an eversible cuff (52) which can be wrapped over a cut end (26) of the descending aorta (18). Distal perfusion can be re-established prior to aortic arch replacement. A second prosthetic element (120), optimised to the patient, is fitted with a replacement for the aortic arch and attached to the descending aorta graft (40). An introducer assembly (30) having a transparent or translucent sheath (70) enables the descending aortic graft element (40) to be deployed without the use of x-rays.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional application,Ser. No. 62/425,368 filed on Nov. 22, 2016, entitled “Graft for Treatingthe Distal Aortic Arch and Descending Aorta in Type A Patients” theentire contents of which are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to a graft assembly for the treatment ofthe descending aorta in patients, particularly Type A patients in whichprosthetic replacement of the aortic arch and, in some instances, thedescending aorta is required. The preferred embodiments disclosed hereinprovide a hybrid assembly with an antegrade graft for treating thedistal aortic arch and descending aorta and a second graft element fortreating the aortic arch and ascending aorta.

Background of the Invention

Surgical treatment of type A patients is complicated and is stillassociated with high morbidity and mortality rates. The orientation ofthe aorta means that surgery has to be carried out in two locations onthe patient. Replacement of the ascending aorta and the aortic arch canbe effected by a median sternotomy. This is generally a successfulprocedure as a sternotomy is a relatively pain free process given thelack of muscular tissue in that region of the chest. Replacement of thedescending aorta requires the patient to be turned onto the side andthen a second access point used, which involves the opening of a side ofthe chest cavity, by breaking the patient's ribs and collapsing thelung. Overall, this procedure is painful and traumatic, with at bestlong convalescence periods and with elevated risk of morbidity andmortality.

Attempts have been made at developing a prosthesis which avoid the needto made the second aperture, by cutting the descending aortatransversally just distal to the arch and implanting into the descendingaorta a stent graft from the side of the sternotomy. The stent graftincludes also aortic arch and ascending aorta graft sections, withbranches for the carotid and subclavian arteries. While this cansignificantly improve surgery times, patient healing and complications,differing surgical and patient means it is difficult to make aprosthetic device which is suitable for all. While some devices may beconfigurable in situ, this adds surgical complication and extendssurgery time.

More specifically, stent-grafts were initially designed to be usedduring type A (DeBakey type 1) dissections. Possible indications fortype A aortic dissections include:

(i) extensive arch tear or proximal descending aortic tear in which thegraft will facilitate the repair;

(ii) presence of severe dynamic malperfusion (distal arch aorticocclusion);

(iii) secure distal anastomosis hemostasis;

(iv) enhance false lumen thrombosis and decrease late aneurysmaldegeneration of the descending aorta, reported in up to 30% of patientsafter DeBakey type 1 repair.

In addition to type A repair, a graft may be used in patients withdistal arch/proximal descending aneurysms or patients with chronicdissected aneurysms following type A repair.

There are reports, mainly from Asian centres, of the usage of tailormade hybrid devices. The incidence of false lumen thrombosis of thedescending aorta is reported in up to 80-90% of patients compared to anincidence of less than 10% in patients without a hybrid stent-graftinserted in the descending aorta. Furthermore these extensive proceduresmay be performed with results comparable to a standard procedure withoutplacement of a hybrid graft. A major drawback of an extended procedureis a rate of paraplegia in 3-7% of patients, a complication which is notreported with procedures without a stent-graft. The risk of paraplegiais mainly related to the extended period of non-perfusion of the distalbody owing to the complex arch reconstruction.

One known device incorporates a four branch graft to the stent.Deployment is complex and arch vessel branch orientation is oftendifficult. The distal anastomosis is performed using a collar on thegraft. Positioning of this collar may be difficult, rendering the distalanastomosis tedious. Distal perfusion during distal anastomosis isimpossible. Another known device has a configuration without branches. Acollar is used for the distal anastomosis with the same limitations asthe branched device. Distal perfusion is also impossible whileperforming the distal anastomosis.

These limitations of known procedures and devices lead to high risk ofmedical complications.

Some examples of prosthetic devices for such uses are disclosed in U.S.Pat. Nos. 5,653,743, 6,767,358, 8,092,511, 8,133,266, WO-2009/145901,EP-1,736,116 and in “Total aortic arch replacement with a novelfour-branched frozen elephant trunk graft: first-in-man results” byMalakh Shrestha et al in European Journal of Cardio-Thoracic Surgery 43(2013) 406-410.

SUMMARY OF THE INVENTION

The present invention seeks to provide an improved implantable medicaldevice and method of treating aortic diseases particularly in Type Apatients.

According to an aspect of the present invention, there is provided agraft assembly including a unitary tubular graft element having alength, a first end, a second end and an axis; a plurality of stentelements extending along a majority of the length of the tubular graftelement from the first end thereof, to provide a stented first portionof the tubular graft element; the tubular element from an end of thefirst stented portion to the second end being free of stents and forminga non-stented second portion of the tubular graft element; wherein thesecond portion is a minor portion of the length of the tubular graftelement; the second portion having a circumference at least large as acircumference of the first portion so as to be eversible over the firstportion for form a coaxially overlapping cuff to the tubular graft.

The graft assembly can be deployed in the descending aorta, with thecuff everted over the severed end of the descending aorta, so as toprovide a prosthetic replacement to the diseased descending aorta and afixation point for a second prosthetic element for the repair of theaortic arch and ascending aorta. The graft assembly has a form which isreadily deployable without needing to make a second entry point into thepatient.

The assembly taught herein is particularly suited for the treatment oftype A dissections and/or thoracic aneurysms where the aneurysm extendsthrough the aortic arch and the descending aorta.

Preferably, the second portion of the tubular graft element has a lengthof 20 to 40 millimetres, most preferably of around 30 to 32 millimetres.This length enables the cuff to cover the thickness and a sufficientlength of the outside of the descending aorta to provide a solidfixation not only of the stented portion of the graft assembly but alsofor a second prosthetic element.

In an embodiment, the first portion of the tubular graft element has alength of around 10 to 20 centimetres, for instance of around 15centimetres. The skilled person will appreciate that the length of stentgraft in the descending aorta will depend on the length of diseasedvessel and the patient's anatomy.

The tubular graft element advantageously has a single lumen. In otherwords, the tubular graft element is a single tubular element such thatthe first and second portions are part of the same tube and preferablylinearly coaxial with one another. The tubular graft element preferablyhas a substantially cylindrical form. In other words, the tubular graftelement preferably has a uniform open diameter throughout its length,that is substantially the same open diameter.

In other embodiments, the tubular graft element may have differentdiameters along its length, for instance to taper and/or to have alarger diameter portion at the unstented (that is, stent free) part ofthe assembly. The stented portion can be tapered to have a smallerdiameter distal.

In practical embodiments the tubular graft element is formed ofpolyethylene terephthalate (PET), polytetrafluoroethylene (PTFE),polyester (for instance Dacron).

The stent elements may be formed of Nitinol, stainless steel or othersuitable materials known in the art.

The graft assembly is advantageously designed for use in the treatmentof the descending aorta, wherein the second portion of the tubular graftelement is eversible over the transversally severed aorta wall. In thisembodiment, a second graft element is preferably sutured to the tubulargraft element, wherein the second graft element is formed to fit to theaortic arch of a patient.

The provision of two separate graft elements means that an aortic archsection can be provided specifically for that patient's condition andanatomy, which can significantly speed up the surgical process andprovide a prosthetic replacement much better suited to that patient.Increased speed and the possibility of re-establishing perfusion intothe descending aorta during the procedure can significantly reduce oreliminate the risk of medical complications caused by the procedure.Moreover, it is possible to re-establish distal perfusion once thethoracic prosthesis (the descending aortic arch graft section) has beendeployed and during the arch replacement.

Providing the possibility to perfuse within the stent-graft duringcirculatory arrest can minimize distal ischemia including to the spinalcord, decreasing or eliminating the risk of paraplegia. The preferredembodiments provide the following additional advantages:

(i) a short and easy pusher rod deployment system;

(ii) a transparent or translucent sheath which allows controlled andprecise graft deployment;

(iii) a proximal un-stented graft portion which can be easily tailoredto the aortic arch wall;

(iv) since the graft is terminated at the level of the transected arch,an endotracheal tube may be inserted and inflated within the hybridstent allowing for distal body perfusion. This may be done before andduring the distal anastomosis.

These advantages can have significant clinical impact. The easy andreliable deployment system may be adapted to many clinical situations inaddition to type A dissections, such as distal arch aneurysms andchronic dissection cases. The possibility to initiate distal perfusionhas significant benefits. First, this ensures distal body perfusionincluding spinal cord perfusion. Paraplegia risk can be significantlylessened and even abolished. Secondly, hypothermia, which is classicallyrequired for this type of surgery, may be significantly reduced. Thistranslates in a shorter cardiopulmonary bypass (CPB) time, lesscoagulation, respiratory and kidney problems (all linked to CPBduration).

According to another aspect of the present invention, there is providedan introducer system including a medical device carrier onto which agraft assembly as herein disclosed is fitted, the graft assembly beingin a radially compressed state on the device carrier; and a sheathfitted over the graft assembly, wherein at least a portion of the sheathoverlying the graft assembly is transparent or translucent.

As the graft assembly is intended to be deployed at an open (severed)end of the descending aorta, opened by sternotomy, the introducer systemin combination with the graft assembly permits deployment without theneed for X-rays or other imaging radiation during the process.

Advantageously, the system includes a proximal end and a distal end, anintroducer tip being present at the distal end; the graft assembly beingcarried on the device carrier with the stented first graft portionthereof disposed facing the distal end and the non-stented secondportion being disposed proximally thereto. The transparent ortranslucent sheath allows the surgeon to locate the unstented cuff atthe location of the cut in the descending aorta, such that the stentedpart of the assembly fits in the aorta substantially in line with thesevered end of the aorta. In this manner, not only is the aorta fullysupported by the stented graft portion but optimal use of the cuff isalso assured.

Advantageously, the sheath is splittable.

According to another aspect of the present invention, there is provideda method of treating aortic disease including the steps of:

opening a patient's aorta at or proximate the aortic arch;

cutting transversally the descending aorta proximate the aortic arch;

disposing into the descending aorta a unitary tubular graft elementhaving a length, a first end, a second end and an axis; a plurality ofstent elements extending along a majority of the length of the tubulargraft element from the first end thereof, to provide a stented firstportion of the tubular graft element; the tubular element from an end ofthe first stented portion to the second end being free of stents andforming a non-stented second portion of the tubular graft element;wherein the second portion is a minor portion of the length of thetubular graft element; the second portion having a circumference atleast large as a circumference of the first portion;

everting the second portion over the transversally severed aorta wall,thereby to form a cuff to the tubular graft element, the cuffoverlapping the aorta wall and the first portion of the tubular graftelement; and

suturing a second graft element to the tubular graft element, whereinthe second graft element is formed to fit to the aortic arch of apatient.

Advantageously, the cuff is sutured to the aorta wall. In the preferredembodiment, the cuff is sutured to a non-everted part of the tubulargraft through the aorta wall. By suturing the graft section to itselfthere can be assured a strong suture tie, as well as a good connectionto the vessel wall.

Preferably, the method includes the step of disposing the stent graftassembly into the descending aorta by means of an introducer assemblyhaving a transparent or translucent sheath overlying the stent graft. Inthis manner, therefore, the stent graft assembly can be disposed intothe descending aorta without X-ray or other imaging procedures.

Other aspects and advantages of the teachings herein are described belowin connection with the preferred embodiments disclosed herein.

BRIEF DESCRIPTION OF THE DRAWING

Embodiments of the present invention are described below, by way ofexample only, with reference to the accompanying drawings, in which:

FIG. 1 is a sketch of a patient showing the point of entry via thepatient's sternum;

FIG. 2 is a sketch depicting an example of aortic disease intended to betreated by the apparatus and method taught herein;

FIG. 3 is a sketch depicting the removal of a diseased aortic archsection of a patient;

FIG. 4 is a sketch depicting the deployment of a two-part graft assemblyas taught herein;

FIG. 5 is a schematic diagram of a preferred embodiment of introducerassembly;

FIG. 6 is a side elevational view of a preferred embodiment of graftassembly for deployment in the descending aorta;

FIG. 7 is a side elevational view of a transparent sheath of thepreferred embodiment of introducer assembly;

FIG. 8 is a side elevational view of the distal end of an embodiment ofintroducer assembly with the stent graft held therewithin;

FIGS. 9 and 10 are schematic diagrams of the distal end of theintroducer assembly of FIG. 8 positioned into the descending aorta of apatient;

FIG. 11 is a schematic diagram of the descending graft element oncereleased from the introducer system;

FIG. 12 is a schematic diagram of the descending graft element with thecuff everted over the descending aorta wall;

FIG. 13 is a schematic diagram of the descending graft element with thedescending stent graft section fitted and distal perfusionre-established;

FIG. 14 is a schematic diagram of an embodiment of graft assembly shownfitted in a patient's aorta; and

FIG. 15 is a diagram of a corrugated elephant trunk deployable by thesystem and method taught herein.

DETAILED DESCRIPTION

It is to be understood that the drawings are schematic only and not toscale. Often, only the principal components relevant to the teachingsherein are shown in the drawings, for the sake of clarity.

The embodiments described below relate to a graft assembly for use as aprosthetic replacement to a diseased aorta and specifically the aorticarch and descending aorta. The assembly may also replace at least aportion of the ascending aorta.

The graft assembly is formed in two sections or elements which areconnected together, typically by suturing, during the surgicalprocedure. The first part of the assembly is a graft element designedand intended to fit into the descending aorta and to terminate justabove a cut or severe line made in the descending aorta. This graftelement and the introducer assembly therefor are described in detailbelow. The second part of the assembly is an arch element intended toreplace at least the aortic arch and often also at least a part of theascending aorta. It is herein referred to as a graft element although itis to be understood that the term “graft” is used in a broad sense.Separating the graft into two parts in this manner, it has been found,can substantially facilitate and improve the surgical procedure, in thata second part specific to the patient's anatomy and diseased conditioncan be provided. Moreover, the placement and attachment of this part tothe heart and branch arteries is notably more straightforward, withoutneeding also to account for a portion of the assembly already deployedin the descending aorta, that is prior coupled to the vessel wall orstill held in or by an introducer assembly. The first part, that is theelement which is deployed in the descending aorta, can be made as asubstantially standard component and can be deployed in a first phase ofthe surgical procedure. Its deployment can be completed before theaortic arch section is fitted and distal perfusion re-establishedquickly. Only once both graft element are connected to their associatedvessels do they need to be connected to one another. The inventors havefound that with this structure it is possible to carry out a prostheticreplacement of this nature within 20 to 30 minutes, that issignificantly faster than existing procedures. Reducing surgical timeand optimising the nature and deployment of the prosthetic device, as ispossible with the teachings herein, can significantly improve thechances of a successful outcome and also reduce the risk of morbidityand mortality.

FIGS. 1 to 4 depict in generalised terms the medical condition addressedherein and the steps of the disclosed surgical procedure to treat thediseased vessels.

The term “diseased” is used herein to refer to a vessel which is in anyway in need of repair. This may be due to vessel damage, to weakening ofthe vessel wall, to disease in the wall tissue, and so on. The skilledperson will be aware of the range of medical conditions which couldbenefit with a treatment of the type discussed herein.

Referring first to FIG. 1 , this depicts the point of entry into apatient for carrying out the procedure taught herein, namely by apatient sternotomy 10, in which the patient's sternum is cutlongitudinally and the patient's chest then opened laterally to gainaccess to the aorta. No other apertures into the patient are required,specifically a second access point in the zone of the descending aorta.

FIG. 2 shows schematically an example of a diseased aorta 12, in whichthe entire aortic arch 14, at least a section of the ascending aorta 16,and at least a section of the descending aorta 18 have diseased arterialwalls which require replacement or support. FIG. 3 depicts the surgicalstep necessary in this instance, namely transversally cutting (severing)the descending aorta 18, in this example proximate the left subclavianartery, the aortic arch together with at least a part of the branchopenings into the right subclavian artery and the carotid arteries, thelatter three being cut beyond the diseased portions thereof. Inaddition, the ascending aorta 16 is also transversally cut, proximatethe heart 22. Following these cuts, the major part 24 of the diseasedaorta 12 can be removed, while the diseased descending aorta 18 is leftin place, thereby saving the need to make a larger opening into thepatient. The procedure requires, as is known in the art, the use of amechanical heart pump and bypass tubing for providing continued bloodflow to the patient's vital organs, as well as the slowing or temporarystoppage of the heart, usually by cooling. As these surgical steps areknown in the art, they are not described in detail herein.

FIG. 4 depicts schematically the aorta 10 with the prosthetic graftaccording to the teachings herein fully deployed. The descending graftelement 40 is shown fitted into the descending aorta 18, and in practicesecured thereto, while an aortic arch graft element 50 is attached tothe descending graft element 40 and fitted in replacement of thepatient's own aortic arch. As the entire procedure can be carried outvia a sternotomy, surgical trauma to the patient, surgery times andtemporary loss of distal perfusion can be significantly reduced. Furtherdetails of the resultant structure and deployment process are describedbelow.

Referring now to FIG. 5 , this shows in schematic form the preferredembodiment of introducer assembly 60. The assembly 60 shown in FIG. 5 isin its pre-use condition. It includes an outer sheath 70 which holds theinternal components, including a device carrier 62. A blunt tip 64,typically a dilator tip, can be seen extending beyond a distal extremity72 of the sheath 70. At the other, proximal, end 66, the assembly isprovided with a handle element 68 for operating the various parts of theintroducer assembly 60. The handle 68 may be of a type well known in theart and is therefore not described in detail herein as its componentsand their operation will be familiar to the skilled person.

The blunt tip 64 allows the assembly 60 to be used without a wire guide,and this may be advantageous in many procedures. However, it ispreferred that the device carrier 62 is in the form of a cannula with alumen passing all the way along the assembly 60 and through the blunttip, thereby allowing the use of a wire guide. A wire guide may beadvantageous in some medical procedures, for instance when the lumen ofthe descending aorta is difficult to access, for instance in when theaorta has dissected. The carrier is preferably made of a stiff material,Nitinol being a preferred option.

In the preferred embodiment, the sheath 70 is a 24Fr (8.0 mm innerdiameter) sheath, having an outer diameter of 26Fr (8.8 mm). The sheathcould be taken down to 20Fr inner diameter without compromisingdeployment force. The sheath 70 is preferably clear, that is transparentor translucent, for the entire of its length, which enables procedure tobe carried out without X-rays, that is under visual control. The sheathmay typically have a length of 30 to 50 centimetres, dependent upon thelength of the stent graft held on the introducer assembly.

The sheath 70 is preferably a splittable or peelable sheath, again of atype known in the art, so that this may be removed to release theimplantable medical device 40 without having to slide the sheath 70 overthe medical device 40. This assists in ensuring that the cuff portion 52is not squashed or folded longitudinally during the deployment process.For this purpose, the sheath may include a pair of pull tabs 74, 76

At least a distal section of the sheath 70, which overlies the graftelement 40, is made of a transparent or translucent material, such thatthe physician can see the graft 40 when the latter is disposed in theintroducer assembly 60. This, as will become apparent below, enables thephysician to locate and deploy the graft element 40 without the need forx-rays or other imaging devices. The sheath 70 can be made of anysuitable material, most preferably polytetrafluoroethylene (Teflon). Itis preferably of a single material and of a single layer.

Although only the distal end of the sheath 70 could be of transparent ortranslucent material, in preferred embodiments the entire length of thesheath 70 is made of such a material and is therefore of unitaryconstruction.

Referring now to FIG. 6 , this shows a preferred embodiment of graftsection forming part of a multi-section prosthetic assembly of the typedisclosed herein. This graft section 40, which may be described as adescending aorta graft section, includes a tubular graft element 42having a distal end 44 and a proximal end 46. The tubular graft element42 is, in this embodiment, cylindrical, that is has the same opendiameter throughout its length. In the embodiment shown, the graft tube42 has an open diameter of around 42 mm, although in practice it maytypically have an open diameter of anything between 30-46 mm, moretypically of 32 to 42 mm. The skilled person will appreciate that thisdiameter is dependent on the anatomy of the patient to be treated.Although the tubular graft element 42 is cylindrical in this embodiment,it need not be so. In other embodiments it could have a varying diameteralong its length, for instance to have a distal diameter that is smallerthan the proximal diameter.

The tubular graft element 42 may be made of any conventional bloodimpervious material such as polyethylene terephthalate,polytetrafluoroethylene, polyester, these being just examples.

The graft section 40 can be considered to be formed of two portions, thefirst portion 50 being a stented portion, while the second portion 52 isunstented (that is, stent free).

The stented portion 50 includes a plurality of stents 54, preferablyformed of Nitinol or stainless steel, which are secured to the grafttubing in any conventional manner. The stents 54 are disposed on theoutside of the graft tubing, although they may be disposed internally ofthe graft tubing or in a combination of the two. In the example shown inFIG. 6 , at the two extremities of the stented portion 50 there are alsoprovided end stents 56, which are fitted to the inside of the grafttubing 44. These end stents may be fitted to the outside of the grafttubing in some embodiments.

The end stents 56 are preferably provided with radiopaque markers, whichmay be of gold or other suitable material. Radiopaque markers are wellknown in the art so as not described in further detail herein.

In this embodiment, all the stents 54, 56 have a zigzag annular shapewith substantially straight stent struts connected together at distaland proximal apices. The stents 54, 56 are separate rings spaced fromone another in the longitudinal direction of the graft tubing 42, asshown in FIG. 6 . In one example, each stent 54, 56 may have a height ofaround 15 mm and the stents may be spaced from one another along thegraft tubing 42 by around 8 mm. In this embodiment, the stented section50 has a length in the region of 150 mm. It will be appreciated, though,that the dimensions of the stents, their heights, spacing, and thelength of the stented section 50 may vary from one practical embodimentto another. There may equally be different numbers of stents from theseven stents depicted in FIG. 6 .

The unstented section 52 extends from an end of the stented section 50and in this example for a length of around 30 mm. The unstented sectionmay typically have a length of anything from around 25-35 mm. In thepreferred embodiment shown in FIG. 6 , the unstented section constitutesaround 17% of the length of the graft sleeve 42. It forms a minor partof the length of the graft sleeve 42 and therefore also of thedescending graft element 40.

In a practical embodiment, the graft 44 has a total length of between100 to 200 mm of which the unstented section is around 30 mm.

While in the embodiment shown in FIG. 6 the graft tubing 44 iscylindrical so as to have the same open diameter throughout its length,other embodiments may have a tapering (frusto-conical) form, typicallywith the larger diameter end being at the unstented section 52. In otherembodiments, the unstented portion 52 may be cylindrical but have alarger open diameter than the stented portion 50, which may equally bycylindrical. In this embodiment, the unstented portion 52 wouldtherefore be wider than the stented section 50, which, as will becomeapparent below, can facilitate the eversion of the unstented portion 52over and outside the stented portion 50. Other non-cylindrical forms areequally contemplated.

The unstented portion 52 acts as a cuff to the prosthetic assembly, forfixing the descending graft element 40 to the descending aorta 18 and asa fixation point for the aortic arch prosthetic element.

Referring now to FIGS. 7 and 8 , these are photographs showing,respectively, the see-through sheath 70 and the distal end of theintroducer assembly 60 with the descending aorta graft section fittedtherein.

In the photograph of FIG. 7 , the proximal end of the sheath 70 isshown. As can be seen, the sheath 70 is, in this example, made of atranslucent material and includes a pair of pull tabs 74, 76 which arediametrically opposed. The sheath 70 is split between the pull tabs74,76, such that when they are pulled apart the split propagates towardsthe everted proximal sheath end 78 and then up the length of the sheath70 to its distal end 72 adjacent the tip 64. The splittable sheath 70has a structural form known in the art.

Referring to FIG. 8 , as can be seen, the graft element 40 is disposedsuch that the stented section 50 is positioned distally and theunstented section 52 is disposed proximally on the introducer assembly60. In practice, the unstented section 52 of the graft element may beplaced in abutment with a pusher member of the carrier 62 (not shown).In other embodiments, in place of or in addition to a pushed member, thegraft element 40 may be tied to the carrier by means of one or morerestraining wires, such as the wires 78 shown extending to the tip 64 inFIG. 8 .

Referring next to FIGS. 9 and 10 , these depict the positioning of theintroducer assembly 60 into the descending aorta 18. The distal end 72of the introducer assembly 60 is positioned into the severed end 26 ofthe descending aorta 18 and in practice, as is described in detailbelow, such that the unstented section 52 of the graft 40 in theintroducer assembly 60 remains above the severed end 26.

As will be apparent from FIGS. 9 and 10 , access to the descending aorta18 is via the sternotomy 10, which as a result avoids the need to make asecond access opening into the patient By way of example only, thedescending aorta 18 is shown having a weakened zone 25, which may be ananeurysm, a dissection or other defect.

The distal end 72 of the introducer assembly 60 is located into thedescending aorta 18 up to the end of the stented portion of 50 the graftelement 40, such that the stented portion 50 resides entirely within thedescending aorta. This portion 50 is chosen to have a length sufficientto bypass the entirety of the weakened zone 25. The unstented (stentfree) portion 52 of the graft element 40, that is the cuff, is keptoutside of the descending aorta and specifically above the cut line 26,as viewed in FIGS. 9 and 10 . This is achievable for the reason that thesheath 70 is transparent or translucent, enabling the physician to seeprecisely and align the graft element 40 in the descending aorta 18.

In FIG. 9 the procedure is shown being performed over a guide wire 80.While this is strictly not necessary, there are some medical conditionsin which this may be advantageous, such as when it is difficult toensure proper placement of the introducer 60 into the main lumen of thedescending aorta.

This may occur, for example, when the aorta 18 is dissected. Anover-the-wire 80 procedure may, though, only be necessary in a fewinstances.

It should also be appreciated that since the procedure is carried outfrom the open sternotomy and removed aortic arch, the introducerassembly 60 can be relatively short, thereby making it easy for thephysician to handle the assembly and position the graft element 40accurately within the descending aorta 18.

Referring now to FIG. 11 , this is a view similar to FIGS. 9 and 10 , inwhich the graft section 40 has been released from the introducerassembly 60, the latter having been removed from the descending aorta18. As can be seen, the stented portion 50 expands to the vessel wall,to be secured thereto, and acts as a prosthetic bypass to the section ofthe descending aorta 18 which it covers. The stented section 50 may beprovided with one or more barbs and one or both ends thereof foranchoring the graft element 40 to the descending aorta 18.

On the other hand, the cuff 52 can be seen extending out of thedescending aorta 18, above the cut line 26. The cuff 52 is folded back,that is everted, in the direction depicted by the arrows in FIG. 10 , soas to overly a part of the descending aorta 18 and also a part of thestented portion 50 of the graft element 40. The cuff 52 may be trimmedto size by the physician.

Referring now to FIG. 12 , this shows the configuration with the cuff 52everted in this manner. The cuff 52, and as a result the entire graftelement 40, is fixed to the descending aorta 18 by means of at least onesuture. In the example shown in FIG. 12 , there is shown a suture line80 extending circumferentially around the cuff. There may be provided aplurality of suture lines or sutures in other arrangements for fixingthe cuff 52 to the descending aorta 18.

It is preferable that the sutures pass all the way through the cuff, thevessel wall and the graft material of the stented portion 50, so as toprovide a very secure attachment of the graft element 40 to thedescending aorta 18. It is not excluded, however, that in someembodiments the sutures 80 may be passed solely through the cuff 52 andthe walls of the descending aorta 18.

In addition to providing a secure attachment, the everted cuff 52secures the top of the descending aorta 18, which can be particularlyadvantageous when the latter is weakened.

The stent graft 40 is deployed antegrade during circulatory arrest. Theuse of a transparent or translucent sheath allows the physician toposition the unstented cuff 52 at the level of the arch transection forperforming distal anastomosis.

The descending aorta graft section can effect an endovascular repair ofthe thoracic aorta, for instance to cover a dissection and thrombosingfalse lumen.

Referring now to FIG. 13 , this shows the graft section 40 in positionin the descending aorta following a distal anastomosis. Once deployed,an endotracheal tube 90 is inserted into the lumen of the graft section40 to re-establish distal perfusion during circular arrest and archreconstruction by means of the aortic arch section of the hybrid graftassembly. The endotracheal tube includes an expandable bulbous head 92which presses against the inner graft wall of the section 40, thereby toseal thereto. A narrow exit aperture 94 in the expandable head 92 allowsfor flow of blood into the descending aorta, as well as expansionpressure to the head 92, thereby establishing distal perfusion.

Distal perfusion through the endotracheal tube is maintained throughoutthe distal anastomosis.

The provision of two separate elements to the hybrid assembly also meansthat an aortic arch section can be provided specifically for thatpatient's condition and anatomy, which can significantly speed up thesurgical process and provide a prosthetic replacement much better suitedto that patient. Increased speed and the possibility of re-establishingperfusion into the descending aorta during the procedure cansignificantly reduce or eliminate the risk of medical complicationscaused by the procedure.

Specifically, providing the possibility to perfuse within thestent-graft during circulatory arrest minimises the risk of distalischemia, including to the spinal cord, thus decreasing or eliminatingthe risk of paraplegia. The preferred embodiments provide the followingadditional advantages:

(i) a short and easy pusher rod deployment system;

(ii) a transparent or translucent sheath which allows controlled andprecise graft deployment;

(iii) a proximal un-stented graft portion which can be easily tailoredto the aortic arch wall;

(iv) since the graft is terminated at the level of the transected arch,an endotracheal tube may be inserted and inflated within the hybridstent allowing for distal body perfusion. This may be done before andduring the distal anastomosis; These advantages have significantclinical impact. The easy and reliable deployment system may be adaptedto many clinical situations in addition to type A dissections, such asdistal arch aneurysms and chronic dissection cases. The possibility toinitiate distal perfusion has significant benefits. First, this ensuresdistal body perfusion including spinal cord perfusion. Paraplegia riskcan be significantly lessened and even abolished. Secondly, hypothermia,which is classically required for this type of surgery, may besignificantly reduced. This translates in a shorter cardiopulmonarybypass (CPB) time, less coagulation, respiratory and kidney problems(all linked to CPB duration).

Referring now to FIG. 14 , this shows an example of an entire graftprosthesis in accordance with the teachings herein, when in situ withina patient. For the sake of clarity, the patient's heart is not depictedin FIG. 12 , the sketch terminating at the heart valve 100.

In this example, the descending aorta graft element 40 is fitted in themanner shown in FIG. 12 and in this example extending beyond the leftsubclavian artery 102. It will be appreciated that the entrance to theleft subclavian artery will be occluded by the stented graft portion 50,in this example necessary as a result of disease of that portion of theaorta. The cuff 52 is everted and sutured in the manner explained aboveand connected to a second graft element 120 which replaces the aorticarch and the ascending aorta, in this example until the heart valve 100,which may the original heart valve or a prosthetic replacement. As canbe seen, the second graft section 120 includes a branch vessel 122 whichleads to the right subclavian artery 104, the right carotid artery 106and the left carotid artery 108. A bypass graft 124 connects from theleft carotid artery to the left subclavian artery 102, therebyaddressing the issue of the obstruction at the entry of the leftsubclavian artery 102 by the graft section 40.

The second graft section 120 is fixed to the first graft section 40 atthe point at which it couples to the distal end of the cuff 52, that isat the point indicated at 130. It is typically sutured to and around thecircumference of the cuff 52 so as to provide an integral structure.

FIG. 15 shows another example of assembly 150, which includes anelephant trunk section 152 for replacement or for lining the aorticarch, and which is sutured to the descending aortic graft element 40 atthe cuff 52. The elephant trunk section, which is a known medicaldevice, can be sutured to the walls of the remaining aortic vessels andcut as appropriate to provide fluid passage to the arteries 104-108. Anelephant trunk element of this type is typically used where there isless extensive damage to the aorta.

As the graft assembly is provided in two sections, it is possible toselect an aortic arch graft element which is specifically designed orsuited to the medical condition to be treated and the patient's anatomy,therefore of optimal design for that purpose. On the other hand, thegraft element 40 for the descending aorta can be provided as a separatecomponent and which is of generally of standard form and size. As thetwo elements 40, 120/150 of the assembly can be attached separately totheir respective aortic vessels and then coupled together only once sofitted, it has been found that overall the surgical procedure is muchfaster and provides a better prosthetic replacement than prior artmethods. In other words, it is possible to choose the best technicaloption for each particular patient. The inventors have found that it ispossible to carry out a surgical procedure with the assembly taughtherein in half an hour or less, which is much faster than existingprocedures with existing devices. In any event early re-establishment ofdistal perfusion is a significant benefit.

The stents used in the stented portion 50 of the graft element 40 may beself-expanding stents or balloon expandable stents. In the case ofballoon expandable stents, the introducer assembly 60 may be providedwith a deployment balloon as part of the device carrier, in a mannerwhich will be apparent to the person skilled in the art.

All optional and preferred features and modifications of the describedembodiments and dependent claims are usable in all aspects of theinvention taught herein. Furthermore, the individual features of thedependent claims, as well as all optional and preferred features andmodifications of the described embodiments are combinable andinterchangeable with one another.

The disclosure in the abstract accompanying this application isincorporated herein by reference.

What is claimed is:
 1. A graft assembly including a unitary tubulargraft element having a length, a first end, a second end and an axis; aplurality of stent elements extending along a majority of the length ofthe tubular graft element from the first end thereof, to provide astented first portion of the tubular graft element; the tubular elementfrom an end of the first stented portion to the second end being free ofstents and forming a non-stented second portion of the tubular graftelement; wherein the second portion is a minor portion of the length ofthe tubular graft element; the second portion having a circumference atleast large as a circumference of the first portion so as to beeversible over the first portion to form a coaxially overlapping cuff tothe tubular graft.
 2. A graft assembly according to claim 1, wherein thesecond portion of the tubular graft element has a length at least one of20 to 40 millimetres.
 3. A graft assembly according to claim 1, whereinthe first portion of the tubular graft element has a length of 10 to 20centimetres.
 4. A graft assembly according to claim 1, wherein thetubular graft element has a single lumen.
 5. A graft assembly accordingto claim 1, wherein the tubular graft element has a substantiallycylindrical form.
 6. A graft assembly according to claim 1, wherein thefirst and second portions of the tubular graft element havesubstantially the same open diameter.
 7. A graft assembly according toclaim 1, for use in the treatment of the descending aorta, wherein thesecond portion of the tubular graft element is eversible over atransversally severed aorta wall.
 8. A graft assembly according to claim1, including a second graft section configured to be sutured to thetubular graft element, wherein the second graft section is formed to fitto the aortic arch of a patient.
 9. An introducer system including amedical device carrier, a graft assembly fitted on the device carrier ina radially compressed state, and a sheath fitted over the graftassembly: wherein: the graft assembly includes a unitary tubular graftelement having a length, a first end, a second end and an axis; aplurality of stent elements extending along a majority of the length ofthe tubular graft element from the first end thereof, to provide astented first portion of the tubular graft element; the tubular elementfrom an end of the first stented portion to the second end being free ofstents and forming a non-stented second portion of the tubular graftelement; wherein the second portion is a minor portion of the length ofthe tubular graft element; the second portion having a circumference atleast large as a circumference of the first portion so as to beeversible over the first portion to form a coaxially overlapping cuff tothe tubular graft; and wherein at least a portion of the sheathoverlying the graft assembly is transparent or translucent.
 10. Anintroducer system according to claim 9, wherein the medical devicecarrier includes a proximal end and a distal end, an introducer tipbeing present at the distal end; the graft assembly being carried on thedevice carrier with the stented first graft portion thereof disposedfacing the distal end and the non-stented second portion being disposedproximally thereto.
 11. An introducer system according to claim 9,wherein the entire length of the sheath is transparent or translucent.12. An introducer system according to claim 10, wherein the sheath ismade from a transparent or translucent plastics material.
 13. Anintroducer system according to claim 12, wherein the sheath is made frompolytetrafluoroethylene.
 14. An introducer system according to claim 9,wherein the sheath is splittable.
 15. An introducer system according toclaim 13, wherein the second portion of the tubular graft element has alength at least one of 20 to 40 millimetres.
 16. An introducer systemaccording to claim 15, wherein the first portion of the tubular graftelement has a length of 10 to 20 centimetres.
 17. An introducer systemaccording to claim 9, wherein the tubular graft element has a singlelumen.
 18. An introducer system according to claim 9, wherein the firstand second portions of the tubular graft element have substantially thesame open diameter.
 19. An introducer system according to claim 9,wherein the tubular graft element is formed of a fabric of polyethyleneterephthalate, polytetrafluoroethylene (PTFE) or polyester.
 20. A methodof treating aortic disease including the steps of: opening a patient'saorta at or proximate the aortic arch; cutting transversally thedescending aorta proximate the aortic arch; disposing into thedescending aorta a unitary tubular graft element having a length, afirst end, a second end and an axis; a plurality of stent elementsextending along a majority of the length of the tubular graft elementfrom the first end thereof, to provide a stented first portion of thetubular graft element; the tubular element from an end of the firststented portion to the second end being free of stents and forming anon-stented second portion of the tubular graft element; wherein thesecond portion is a minor portion of the length of the tubular graftelement; the second portion having a circumference at least large as acircumference of the first portion; everting the second portion over thetransversally severed aorta wall, thereby to form a cuff to the tubulargraft element, the cuff overlapping the aorta wall and the first portionof the tubular graft element; and suturing a second graft element to thetubular graft element, wherein the second graft element is formed to fitto the aortic arch of a patient.